Central database at the EMA

The PSUR Repository is a central database at the European Medicines Agency (EMA) for the submission, archiving and management of all periodic safety update reports (PSURs) and the associated process documents (assessment reports, response documents, comments, etc.).

Use of the PSUR Repository has been mandatory for all PSUR submissions since June 13, 2016. The previous rules for submission in the individual member countries of the EU have been suspended since this date. This also applies to PSUR submissions for active substances that are not on the EURD list and for which therefore no PSUR Single Assessment (PSUSA) procedure is carried out, but the PSUR assessment is carried out at national level in the EU member countries.

For information on the PSUR Repository and its mandatory use, see:

In case of problems with the submission of PSURs to the PSUR Repository, please contact the EMA Service Desk Portal:

In addition, BfArM would like to point out the legal obligation of pharmaceutical entrepreneurs to provide information on their medicinal products in accordance with Article 57(2) of Regulation (EC) No 726/2004. According to this legal provision, pharmaceutical entrepreneurs must submit information for their medicinal products authorized in the EU to the European Medicines Agency (EMA) in the electronic format known as the "Article 57 format" or the "eXtended EudraVigilance Product Report Message" (XEVPRM) format. They are also required to keep this drug information up to date.

For more information, see: